monoclonal antibody in treating patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma

Conditions: Leukemia; Lymphoma

Summary: rationale: monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. purpose: phase i trial to study the effectiveness of monoclonal antibody therapy in treating patients who have relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.

objectives: * determine a recommended phase ii dose of idec-152 monoclonal antibody in patients with relapsed or recurrent chronic lymphocytic leukemia. * determine the safety profile of this drug in these patients. * determine the pharmacokinetics and pharmacodynamics of this drug in these patients. * determine the efficacy of this drug in these patients. outline: this is an open-label, multicenter, dose-escalation study. patients receive idec-152 monoclonal antibody iv over at least 2 hours on days 1, 2, 8, 15, and 22. cohorts of 3-10 patients receive escalating doses of idec-152 monoclonal antibody until the maximum tolerated dose (mtd) is determined. the mtd is defined as the dose preceding that at which at least 2 of 3, 2 of 6, or 3 of 10 patients experience dose-limiting toxicity. patients are followed every 3 months for 2 years and then every 6 months thereafter. projected accrual: a total of 15-50 patients will be accrued for this study within 6 months.

Eligibility criteria:
disease characteristics: * histologically confirmed chronic lymphocytic leukemia or small lymphocytic lymphoma * stage iii-iv or * stage i-ii, if determined to have disease progression evidenced by 1 of the following characteristics: * rapid doubling of peripheral lymphocyte count * progressive lymphadenopathy * progressive splenomegaly * b symptoms * grade 2 or 3 fatigue * cd23+ disease * progressive disease after at least 1 prior chemotherapy course patient characteristics: age * 18 and over performance status * who 0-2 life expectancy * at least 6 months hematopoietic * platelet count at least 50,000/mm\^3 hepatic * bilirubin no greater than 2.0 mg/dl * ast/alt no greater than 1.5 times upper limit of normal (uln) renal * creatinine no greater than 1.5 times uln cardiovascular * no new york heart association class iii or iv cardiac disease * no myocardial infarction within the past 6 months * no unstable arrhythmia * no evidence of ischemia on ekg within the past 14 days pulmonary * fev_1 at least 60% of predicted * dlco at least 55% of predicted other * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception during and for 3 months after study treatment * hiv negative * no secondary malignancy requiring active treatment (except hormonal therapy) * no serious nonmalignant disease that would preclude study participation * no active uncontrolled bacterial, viral, or fungal infection * no clinically active autoimmune disease prior concurrent therapy: biologic therapy * more than 4 weeks since prior anticancer biologic therapy * more than 4 weeks since prior anticancer radioimmunotherapy * no prior exposure to idec-152 or anti-cd23 antibodies chemotherapy * see disease characteristics * more than 4 weeks since prior anticancer chemotherapy endocrine therapy * concurrent hormonal therapy allowed for second malignancy radiotherapy * more than 4 weeks since prior anticancer radiotherapy surgery * more than 4 weeks since prior major surgery (except for diagnostic surgery) other * more than 4 weeks since prior anticancer investigational therapy * no other concurrent anticancer therapy

Keywords: refractory chronic lymphocytic leukemia stage i chronic lymphocytic leukemia stage ii chronic lymphocytic leukemia stage iii chronic lymphocytic leukemia stage iv chronic lymphocytic leukemia noncontiguous stage ii small lymphocytic lymphoma recurrent small lymphocytic lymphoma stage i small lymphocytic lymphoma stage iii small lymphocytic lymphoma stage iv small lymphocytic lymphoma contiguous stage ii small lymphocytic lymphoma